FDA approval for Emrosi ((minocycline hydrochloride extended release capsule to treat rosacea

Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, said, “With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the U.S. suffering from rosacea. Rosacea is a difficult to treat skin condition and based on the favorable results from our Phase III clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition. Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea. Journey Medical is committed to bringing cutting-edge innovation to patients with dermatological conditions and the healthcare professionals who treat them.”

The approval of Emrosi is supported by positive data from Journey Medical’s two Phase III clinical trials for the treatment of rosacea. The Phase III clinical trials met all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues. Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea  40 mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count in both studies.

Journey Medical is completing the manufacturing of Emrosi for the U.S. market and anticipates that initial supply will be available late in the first quarter or early in the second quarter of 2025. Journey Medical intends to commercialize Emrosi in the U.S. with its dermatology-focused commercial organization. In line with the approved label, Journey Medical will execute a launch strategy to drive Emrosi toward becoming a new oral standard of care for adult rosacea patients.

Journey Medical Corporation, a partner company of Fortress Biotech, Inc, has announced an agreement with Dr. Reddy’s Laboratories Ltd. for the collaboration in development and commercialization of the DFD-29 program (minocycline modified release capsules 40 mg) for the treatment of rosacea. Journey Medical acquired global commercialization rights in the U.S. and Europe from Dr. Reddy’s, and Dr. Reddy’s has retained rights to the program in select markets including Brazil, Russia, India, and China.